Dáil Éireann Debate, Wednesday - 2 November 2016
353. Deputy Pat Buckley asked the Minister for Health the status of his work to provide new treatments for Dravet syndrome in view of meetings with families affected and their call for access to cannabidiol. [32896/16]
View answerCannabidiol (CBD) is derived from cannabis. However, since it does not have psychoactive properties it is not controlled under the Misuse of Drugs Acts.
While I am aware that CBD oil is sometimes marketed as a nutritional or dietary supplement, it should be noted that it is not authorised as a medicinal product in Ireland. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA) or, in the case of certain medicinal products, the European Medicines Agency. A determination on an application for authorisation of a medicinal product is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements. I have no role in the process of authorising medicinal products.
To date, the HPRA has not received any applications for authorisation for any cannabis-based product other than the one authorised in 2014. If other cannabis-based medications come to market, and the marketing authorisation holder seeks to have the product made available in Ireland, it is likely that further legislative changes may be required to accommodate such a product.
Where a medicinal product is not authorised in Ireland, a licensed wholesaler may import it if it has been prescribed by a doctor for a patient under his/her care, on his/her direct responsibility and in order to meet the special needs of a patient. Therefore, if a CBD oil preparation does not contain an ingredient which is a controlled substance, such as THC, it may be feasible to have that product imported and used in Ireland, in accordance with specific conditions, should a patient’s doctor be of the opinion that this is an appropriate treatment.
Patients suffering from Dravets syndrome should firstly discuss treatment options with their consulting doctor.
The issue of permitting the use of cannabis-based products for medical purposes in Ireland is likely to be considered in the context of the new National Drugs Strategy and I understand the Oireachtas Health Committee will consider the matter in the coming weeks.
I have met with affected families and am very sympathetic to the situation they are in, and I have also discussed this issue with the HPRA. I look forward to the deliberations of the Health Committee, and hope we can proceed on a cross-party basis to examine this matter on behalf of the patients.
